Breast Neoplasm, Exercise23AA01NCT07666724
Oncology Treatment Related Ocular Surface Changes
An observational study of Breast Neoplasm, Exercise, run by Semmelweis University at 1 site in Hungary.
Trial summary
clinical trial The goal of this clinical trial is to learn if drug trastuzumab works to treat HER2 positive mamma carcinomas without causing dry eye related ocular surface changes in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasm, Exercise
- What is being tested?
- Trastuzumab (Herceptin)
- How many people
- 35 participants
- Where
- 1 siteHungary
- Study dates
- 18 May 2021to 31 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: location Semmelweis University Budapest
Who may be able to join
- Patients received the following anti-HER2 therapies (according to protocol and national guidelines in Hungary at the time) administered either as monotherapy or in combination based on disease characteristics: trastuzumab (alone or in combination with pertuzumab), pertuzumab (in combination with trastuzumab), trastuzumab emtansine (monotherapy), and trastuzumab deruxtecan (monotherapy).
- General eligibility criteria for anti-HER2 therapy included patients over the age of 18 years, of either sex, with invasive breast cancer showing HER2 overexpression as determined by immunohistochemistry (IHC) and/or fluorescence in situ hybridization (FISH).
Who cannot join
- not willing to participate
- any preexisting ocular disease
- Eastern Cooperative Oncology Group (ECOG) performance status higher than 2 -inadequate bone marrow, renal, and hepatic function
- untreated cardiac disease
- left ventricular ejection fraction (LVEF) of less than 50%.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ophthalmological Examination of Changes Induced by Therapy and Ocular Surface Abnormalities in Patients With Cancer
clinical trial
The goal of this clinical trial is to learn if drug trastuzumab works to treat HER2 positive mamma carcinomas without causing dry eye related ocular surface changes in adults. The main questions it aims to answer are:
Read more
Does trastuzumab increase the dry eye related subjective symptoms? Does trastuzumab cause increased tear film instability and corneal epithelial staining (Oxford score), and lipid layer deterioration? Is a dose-dependent ocular surface effect identifiable attributable to trastuzumab and their modification by patient age?
Participants will:
Take drug trastuzumab-based chemotherapy based on the decision of the local onco-team.
Visit the clinic once every 3 months for checkups and tests Keep a diary of their ocular symptoms Make ocular examination and measure dry eye related parameters
- Conditions
- Breast Neoplasm, Exercise
- Being tested
- Trastuzumab (Herceptin)
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab (Herceptin)Drug
trastuzumab treatment as the oncoteam advised
| Study group | Role | What they receive |
|---|---|---|
| Trastuzumab treatment | Not described Receives: Drug: Trastuzumab (Herceptin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear film break up time
Zero is equivalent to no stability, very short breaking up time. The more seconds, the longer the time and higher the stability, during the tear film remains healthy and stable .
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Ocular Surface Disease Index
Zero is equivalent to no pain or discomfort and the higher the points, the more pain and discomfort is detected. Range 0-100.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start18 May 2021
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Neoplasm, ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barcsay-Veres Amarilla, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666724
- Sponsor's protocol ID
- OGYEI/18718-6/2021
- Acronym
- 23AA01
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ophthalmological Examination of Changes Induced by Therapy and Ocular Surface Abnormalities in Patients With Cancer
- ClinicalTrials.gov ID
- NCT07666724
- Acronym / sponsor ID
- 23AA01 / OGYEI/18718-6/2021
- Conditions
- Breast Neoplasm, Exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 18 May 2021 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
clinical trial
The goal of this clinical trial is to learn if drug trastuzumab works to treat HER2 positive mamma carcinomas without causing dry eye related ocular surface changes in adults. The main questions it aims to answer are:
Does trastuzumab increase the dry eye related subjective symptoms? Does trastuzumab cause increased tear film instability and corneal epithelial staining (Oxford score), and lipid layer deterioration? Is a dose-dependent ocular surface effect identifiable attributable to trastuzumab and their modification by patient age?
Participants will:
Take drug trastuzumab-based chemotherapy based on the decision of the local onco-team.
Visit the clinic once every 3 months for checkups and tests Keep a diary of their ocular symptoms Make ocular examination and measure dry eye related parameters
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trastuzumab treatment | – | Drug: Trastuzumab (Herceptin) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- location Semmelweis University Budapest
Key inclusion criteria (2 listed)
- Patients received the following anti-HER2 therapies (according to protocol and national guidelines in Hungary at the time) administered either as monotherapy or in combination based on disease characteristics: trastuzumab (alone or in combination with pertuzumab), pertuzumab (in combination with trastuzumab), trastuzumab emtansine (monotherapy), and trastuzumab deruxtecan (monotherapy).
- General eligibility criteria for anti-HER2 therapy included patients over the age of 18 years, of either sex, with invasive breast cancer showing HER2 overexpression as determined by immunohistochemistry (IHC) and/or fluorescence in situ hybridization (FISH).
Key exclusion criteria (5 listed)
- not willing to participate
- any preexisting ocular disease
- Eastern Cooperative Oncology Group (ECOG) performance status higher than 2 -inadequate bone marrow, renal, and hepatic function
- untreated cardiac disease
- left ventricular ejection fraction (LVEF) of less than 50%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trastuzumab (Herceptin)trastuzumab treatment as the oncoteam advised | Drug | Trastuzumab treatment |
Primary outcome
Tear film break up time
Time frame: through study completion, an average of 1 year
Zero is equivalent to no stability, very short breaking up time. The more seconds, the longer the time and higher the stability, during the tear film remains healthy and stable .
1 secondary outcome
Ocular Surface Disease Index
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasm, Exercise, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear film break up time (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.